Two AstraZenecon drugs have been approved by CHMP for heart failure and slow pulmonary resistance

On October 19th AstraZeneca announced that Forxiga (dapagliflozin, Dagliflozin) extended adaptive disorder had been recommended by the European Medicines Agency (EMA) Human Medicines Commission (CHMP) for use in the European Union (EU) for the treatment of adult patients with symptomatic chronic heart failure (HFrEF) with reduced blood test scores, regardless of type 2 diabetes (T2D).
At the same time, the company Trixeo Aerosphere (Fumaric Acid Fomotro/Brominated Paramonium Bromide/Budinide) is also recommended by CHMP for EU marketing for the treatment of adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) in combination with inadequate inhalation of corticosteroids (ICS) and long-acting beta-2-inflammatory agents (LABA) or INA and long-acting venom-alkali antagonists.
based on the results of the landmark Phase 3 clinical trial DAPA-HF published in the New England Journal of Medicine, CHMP gave positive advice on Forxiga's adaptation expansion.
DAPA-HF is an international multi-center, parallel grouping, randomized double-blind Phase 3 clinical trial in 4,744 patients with or without T2D in HFrEF (LVEF≤40%) to assess the efficacy and safety of 10mg Forxiga in standard care compared to placebo.
compound endpoint is the time of death of the first worsening HF event (hospitalization or equivalent; i.e. emergency HF visit) or CV.
follow-up time was 18.2 months.
DAPA-HF study shows that forxiga combined care standards reduce the risk of cardiovascular (CV) death or heart failure (HF) by 26% compared to placebos (risk ratio. 0.65-0.85;p .lt;0001) (Absolute risk reduction .ARR. .9% (16.3% and 21.2% of the patients who occurred).
also found that one CV death or hHF or HF-related emergency visits could be avoided for every 21 patients treated during the trial.
addition, forxiga's safety is consistent with the drug's existing safety.
CHMP recommends Forxiga for the treatment of symptomatic chronic HFrEF adults.
May 2020, Farxiga was approved in the United States to reduce the risk of CV death and hHF in adult HF patients (NYHA II-IV) with reduced blood test scores, and reached all major and secondary endpoints in Phase 3 trial DAPA-CKD for patients with chronic kidney disease (CKD).
addition, Forxiga will conduct a randomized controlled phase 3 trial of DAPA-MI in patients without T2D for acute myocardial infarction (MI) or post-heart attack.
Trixeo AerosphereTrixeo Aerosphere is a three-drug combination therapy, a single inhaler consisting of the LABA drug Fumaric acid fomotro, the LAMA class drug brominated glycol pyridoxine, and the ICS class drug Budinide, which is delivered through a pressurized metered-dose inhaler.
has been approved in Japan, China and the United States for the treatment of COPD patients (brand name Breztri Aerosphere).
chMP recommendation, mainly based on phase 3 clinical trials ETHOS results.
This is a randomized, double-blind, multi-center, parallel group, 52-week Phase 3 clinical trial to assess the efficacy and safety of Trixeo Aerosphere in patients with moderate to severe COPD with a history of exacerbation in the past year.
end point of the disease is the occurrence of moderate or severe deterioration.
study published in the New England Journal of Medicine showed that the rate of moderate or severe deterioration in patients treated by Trixeo Aerosphere was statistically significantly reduced by more than 52 weeks compared to the two-drug therapy Bevespi Aerosphere (pyridoxine/fumatic acid fomotro) and PT009 (Budinide/Fumaric acid fomotro).
, CHMP recommendations were also supported by positive data from random, double-blind, parallel groups, 24 weeks, chronic dosing, and multi-center Phase 3 trial KRONOS.
two trials, the drug's safety and tolerance were consistent with dual-drug combination therapy.
source: 1. Forxiga recommended for approval in the EU by CHMP for heart failure2. Trixeo Aerosphere recommended for approval in the EU by CHMP for the maintenance treatment of COPD Original title: AstraZenecon Forxiga and Trixeo Aerosphere approved by CHMP for heart failure and COP